Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET)

Cancer Clinical Trial

— HX-4  

Official title:

Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690053
• Other study ID #: 08-3-040
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2008
• Last updated: June 29, 2009
• Start date: August 2008

Study information

• Verified date: February 2009
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia.

Description:

To determine the toxicity of the hypoxia PET-tracer [18F]-HX4 in cancer patients in two dose-steps:

• Step 1 (3-6 patients): a single dose of maximum 6 mCi (222 MBq) dose of [18F]HX4 (which contains a maximum of 15 μg HX-4) via a bolus IV injection.

• Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of [18F]HX4 (which contains a maximum of 27 μg HX-4) via a bolus IV injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options.

• Normal white blood cell count and neutrophils

• Normal platelet count

• No anaemia requiring blood transfusion or erythropoietin

• Adequate hepatic function: Total bilirubin = 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase = 2.5 x ULN for the institution).

• Calculated Creatinin clearance at least 60 ml/min

• No administration of Fluor-18 in the previous 24 hours

• Capable of complying with study procedures

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• Injection of HX-4
In step 1: 1 injection of HX-4 (max.6mCi (222MBq)) In step 2: 1 injection of HX-4 (max.12mCi 444MBq)

Locations

Country	Name	City	State
Netherlands	Maastricht Radiation Oncology (MAASTRO clinic)	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity (CTCAE 3.0)		9 months	Yes
Secondary	Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan)		9 months	Yes